Pain management kit for administration of medication

ABSTRACT

A pain management kit for the administration of medication and a related method of use is disclosed. The pain management kit includes the primary medical supplies for performing a continuous nerve block procedure, preferably in a single, sterile container. Specifically, the kit may contain medical supplies to create a sterile field, perform a local anesthetic procedure and to perform a continuous nerve block procedure. Preferably, the contents of the kit are arranged in the general order of their use.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.10/796,630, filed Mar. 9, 2004, abandoned, which is a continuation ofU.S. application Ser. No. 10/123,436, filed Apr. 15, 2002, abandoned,which claims priority from, U.S. Provisional Patent Application No.60/283,800, filed Apr. 13, 2001, the entireties of which are herebyincorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to pain management systems, and more specificallyto a catheter-based infusion system for the administration of fluids.Most specifically, this invention relates to a pain management kit forperforming a nerve block procedure.

2. Description of the Related Art

Prior to performing a surgical operation on a part of the body, such asfor example the arms or legs, it may be desirable to perform a nerveblock in order to anesthetize a nerve bundle in a part of the bodyproximate to where surgery will occur. Often, a catheter-based infusionsystem is utilized to both block the nerve bundle for surgery and toprovide a continuous, low flow rate of the anesthetic over a period oftime (e.g., 2–3 days following surgery) for post-operative painmanagement.

One approach is to use an epidural needle having an integral conductivewire such that a small amount of current may be pulsed through theneedle by a nerve stimulator (i.e., a current generator). When theepidural needle is probed into the general area of the desired nervebundle, the pulsing current stimulates the nerve and causes a motorresponse to assist in properly locating the needle. Once proper locationof the needle is achieved, a test dose of the anesthetic may be providedthrough the epidural needle. Proper positioning of the needle isverified by a failure to obtain a motor response to the currentstimulation. At this point, a catheter may be introduced through theneedle to administer the anesthetic and maintain the nerve block.

The above-described procedure is typically performed by ananesthesiologist in a prep room outside of the operating room (OR)because a period of time is necessary for the nerve block to becomeeffective and because time in the OR is at a premium. This procedure isoften very time consuming and inefficient due to the volume of medicalsupplies and items that must be obtained, opened and arranged in orderto perform the nerve block.

First, the anesthesiologist must set up a sterile field around thedesired pierce site. To do this, one or more packages containing thenecessary supplies, such as a drape, iodine solution and prep sticks toapply the iodine solution, must be obtained and opened. Next, theepidural needle, infusion pump, infusion supplies (tubing, clamps,connectors, flow meter, filter, etc.), catheter and anesthetic, whichare typically packaged separately, must be obtained and prepared.Additional medical supplies, such as a local anesthetic, needles andsyringes are also necessary to numb the desired pierce site. Theseproducts are also likely to be packaged separately from each other, aswell as from the supplies listed above.

The collection, opening and preparation of the above-listed medicalsupplies is time consuming and one or more items may be misplaced orforgotten. In addition, a large amount of waste is generated from theseparately packaged items. Therefore, a need exists for an improvedsystem of providing the primary medical supplies necessary to perform acontinuous nerve block in a sterile and efficient manner.

SUMMARY OF THE INVENTION

One aspect of the present invention provides a pain management kitcontaining the primary supplies necessary to perform a continuousperipheral nerve block in a single, sterile container which may beeasily stored and transported. Advantageously, the pain management kitis easy to open and its contents are arranged such that the items may beretrieved from the kit generally in the order of their subsequent use inthe nerve block procedure.

Briefly stated, the pain management kit provides supplies necessary tocreate a sterile field, locally anesthetize the desired pierce site andperform the nerve block in a single, sterile container. Generally, theonly additional supplies required are a nerve stimulator, an infusionpump, and the desired infusion drug. The nerve stimulator is anelectronic device that is non-sterile and reusable, therefore it is notdesirable to package it with the pain management kit. Likewise, theinfusion pump may be an electronic device, but is preferably amechanical pump. The infusion pump may also be reused, but, if of atypical mechanical variety, is inexpensive enough to be discharged withthe patient. Because the infusion pump is reusable, and not required tobe sterile, it is also desirably not included with the kit.Additionally, the choice of anesthetic drug may vary by doctorpreference and/or patient need. Therefore, the drug is advantageouslyomitted from the pain management kit.

One embodiment provides a pain management kit with a plurality ofmedical items secured within a container configured such that themedical items remain sterile at least until the container is opened. Themedical items include sterile field supplies, local anesthetic suppliesand continuous nerve block supplies.

For purposes of summarizing the invention and the advantages achievedover the prior art, certain objects and advantages of the invention havebeen described hereinabove. Of course, it is to be understood that notnecessarily all such objects or advantages may be achieved in accordancewith any particular embodiment of the invention. Thus, for example,those skilled in the art will recognize that the invention may beembodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught herein without necessarilyachieving other objects or advantages as may be taught or suggestedherein.

All of these embodiments are intended to be within the scope of theinvention herein disclosed. These and other embodiments of the presentinvention will become readily apparent to those skilled in the art fromthe following detailed description of the preferred embodiments havingreference to the attached figures, the invention not being limited toany particular preferred embodiment(s) disclosed.

Further aspects, features and advantages of the present invention willbecome apparent from the following drawings and detailed descriptionintended to illustrate, but not to limit, the concepts of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a pain management kit generallycontaining the primary items necessary to perform a continuous nerveblock;

FIG. 2 is an enlarged view of the pain management kit of FIG. 1illustrating the protective cover in a partially opened position andexposing a peripheral lip of the outer container;

FIG. 3 is an exploded view of the pain management kit, including asterile field tray and a main tray for holding certain items included inthe kit;

FIG. 4 is a top view of the sterile field tray of FIG. 3 with itspreferred contents exploded therefrom. A preferred positioning of thecontents within the sterile field tray is illustrated in phantom;

FIG. 5 is a top view of the main tray of FIG. 3 with its contents in apreferred arrangement;

FIG. 6 is a side view of the main tray of FIG. 5, illustrating certaininternal features in phantom;

FIG. 7 is an illustration of an infusion system and catheter of the painmanagement kit of FIG. 1;

FIG. 8 is an illustration of a portion of the nerve block procedureusing medical supplies contained in the kit of FIG. 1; and

FIG. 9 is an illustration of a subsequent portion of the nerve blockprocedure using medical supplies contained in the kit of FIG. 1.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The preferred embodiment of the pain management kit is illustrated inthe context of a kit for use in performing a continuous nerve block suchas, for example, but without limitation, an interscalene block, a lumbarplexus block or a femoral nerve block. However, as will be understood bythose of skill in the art, the pain management kit can be used withother surgical procedures where it is desirable to provide sterile painmanagement medical supplies in a single package.

To assist in the description of the system and method of use disclosedherein, the following terms are used. The term “distal” refers to a sitethat is away from a specified site. The term “proximal” refers to a sitethat is close to a specified site. Expressed alternatively, a sitetermed “proximal” is measurably closer to a specified reference pointthan a site termed “distal.” The term “downstream” refers to directionalmovement of the liquid drug from the infusion pump to the block site. Anobject or site referred to as “downstream” of another object or sitemeans that the “downstream” object or site is proximal the block siterelative to the other object or site. Similarly, an object or sitereferred to as “upstream” to another object or site means that the“upstream” object or site is proximal the infusion pump site relative tothe other object or site. Expressed alternatively, the “downstream”object is proximal the block site and the “upstream” object is distalthe block site.

The “block site” is the area within the body of the patient proximatethe nerve bundle to be anesthetized. The “pierce site” is the site wherethe patient's skin is pierced to allow the epidural needle and,subsequently, the catheter to extend therethrough and arrive at theblock site to administer the drug.

Description of the Pain Management Kit

With reference to FIGS. 1 and 2, a preferred pain management kit,generally indicated by the reference numeral 10, is illustrated. Thecontents of the kit 10 are contained within a relatively shallow,pan-shaped outer container 12. The outer container 12 is preferably athermoplastic material suitable for use in a sterile medical environmentand is preferably manufactured into a desired shape by thermo-forming.However, other suitable materials and processes may be used tomanufacture the outer container 12.

The outer container 12 includes a generally rectangular base and fourside walls extending substantially normally upward therefrom. The sidewalls terminate in a peripheral lip 16 which defines a generally planaradhesive surface 18 and an integral, generally planar outer surface 20,which is preferably disposed at a height below the adhesive surface 18.

A protective cover 14, generally sized to be flush with the lip 16 ofthe outer container 12, is secured over the opening of the outercontainer 12. The protective cover 14 secures, and keeps sterile, thecontents of the pain management kit 10 within the space between theouter container 12 and the protective cover 14. The protective cover 14is preferably manufactured from a paper fiber material with a waterproofadditive suitable for use in a sterile, medical environment. However,other suitable types of materials including, but not limited to,plastics or PVC may also be used in manufacturing the protective cover14.

The protective cover 14 is secured to the adhesive surface 18 of theouter container 12, preferably with a non-toxic adhesive suitable foruse in a sterile, medical environment. A desired adhesive would providesufficient adhesive force to secure the protective cover 14 to the outercontainer 12 during storage and transport, while still allowing removalupon use without necessitating excessive removal force. Advantageously,a space is created between the outer surface 20 of the lip 16 and anedge portion 22 of the protective cover 14 to the outside of theadhesive surface 18. This arrangement allows the user of the kit 10 tograsp the edge portion 22 of the cover 14 to facilitate its removal fromthe outer container 12.

With reference to FIG. 3, an exploded view of the pain management kit 10is illustrated, with the protective cover 14 completely removed and thecontents of the kit 10 removed therefrom.

Preferably, as packaged, a sterile wrap 23 is placed underneath thecontents of the pain management kit 10, inside the outer container 12,and folded over to cover the contents of the kit 10 (FIG. 2). Thesterile wrap 23 is preferably of a generally square shape and sizedappropriately such that, when folded, the wrap 23 covers the entirecontents of the pain management kit 10 and overlaps itself. Preferably,as illustrated, the corners of the sterile wrap 23 are aligned with thesides of the outer container 12. Each of the corners are folded over thecontents of the kit 10 and toward the center of the outer container 12to achieve the desired overlap of the sterile wrap 23 and substantiallyseal the contents of the pain management kit 10. The sterile wrap 23 maythen be taped to itself in order to maintain the folded position.

In addition to the outer container 12, protective cover 14 and sterilewrap 23, the kit 10 also includes a sterile field tray 24 and a maintray 26. Similar to the outer container 12, the sterile field tray 24and main tray 26 are preferably thermo-formed from a thermoplasticmaterial suitable for use in a sterile medical environment.

The contents of the kit, which are preferably the primary medicalsupplies for performing a continuous nerve block, and relatedpreparatory procedures, are contained on or within the sterile fieldtray 24 and the main tray 26. The sterile field tray 24, advantageously,is held within a portion of the main tray 26 such that the top of thesterile field tray 24 is generally flush with the top of the main tray26. In this manner, space within the outer container 12 of the painmanagement kit 10 is effectively utilized. However, the top of thesterile field tray 24 may also be located above or below the top of themain tray 26.

The sterile field tray 24 generally holds the medical supplies forcreating a sterile field around the pierce site P (FIG. 8). The primarymedical supplies for performing a local anesthetic procedure, as well asthe nerve block procedure, and other general items are held within, oron, the main tray 26. Generally, the items in the kit 10 are disposedfrom top to bottom in the order in which they will be used in the normalcourse of the entire pre-operative nerve block procedure.Advantageously, this allows convenient access to the necessary medicalsupplies as they become needed, thus saving time and lending to anefficient, and uninterrupted, performance of the procedure.

With continued reference to FIG. 3, the illustrated sterile field tray24 is nested to one side of the main tray 26 and disposed aboveadditional medical supplies held within the main tray 26 such that thesterile field tray 24 is readily accessible without disturbing the othercontents of the kit 10. This arrangement is advantageous becausepreparation of a sterile field around the desired pierce site P istypically the first step in a nerve block procedure and, as mentionedpreviously, the sterile field tray 24 preferably contains the necessarymedical supplies to perform the entire sterile field preparation.

Preferably, an absorbent towel 27 is positioned on the side of the maintray 26 opposite the sterile field tray 24. The absorbent towel 27 ispreferably constructed of a typical, disposable material suitable foruse in a sterile, medical environment. Additionally, the towel 27 is ageneral use article and may be utilized throughout the nerve blockprocedure. Accordingly, the towel 27 is advantageously disposed at ornear the top of the pain management kit 10.

A standard surgical drape 28 is provided, preferably, on top of theother contents of the sterile field tray 24. The drape may be a varietyof shapes and sizes and preferably includes a cutout portion that mayalso vary in shape and size. As is conventional, the drape 28 is used tocover the area around where the nerve block is to be performed, whilethe cutout provides access to the desired pierce site P.

With reference to FIG. 4, the sterile field tray 24 and its remainingcontents are illustrated in greater detail. The contents, in addition tothe drape 28, preferably include a packaged skin prep pad 30, a packageof iodine solution 32 and a plurality of prep sticks 34. The drape 28,along with the above-mentioned contents are sufficient to create asterile field so that the remainder of the nerve block procedure may beperformed. In the illustrated embodiment, three (3) prep sticks 34 areprovided, however, this number may be adjusted in accordance with therequirements of the specific pain management procedure. In addition, oneor more of the above-mentioned items may be omitted, or other desirablemedical supplies may be provided in addition or in the alternative.

As illustrated in FIG. 4, a plurality of gauze pads 36 are also providedin the sterile field tray 24. Preferably, four (4)-8 ply, 4″×4″ gauzepads 36 are provided in the sterile field tray 24 underneath the prepsticks 34. The gauze pads 36 are not necessarily utilized to establishthe sterile field, but may be set aside, along with the tray 24, forlater use.

The sterile field tray 24 preferably has a wall 38 that divides the tray24 into two compartments 40, 42. The compartment 40 contains the prepsticks 34 and gauze pads 36, while the compartment 42 contains the skinprep pad 30 and iodine solution 32. The compartment 40 may additionallyinclude a pair of angled side walls 43 and a central bridge 44, both ofwhich desirably contain a plurality of strengthening ribs 46. The sidewalls 43, bridge 44 and ribs 46 all add structural integrity to thesterile field tray 24, allowing a minimum of material to be used inmaking the tray 24. Since the tray is disposable, this is advantageousin that less material is discarded and/or recycled.

The side walls 43 and bridge 44 also provide for ease of removal of thecontents of the compartment 42, namely the skin prep pad 30 and iodinesolution 32. The central bridge 44 supports the contents of thecompartment 42 at a height above the base of the sterile field tray 24.Preferably, the skin prep pad 30 is on top of, and supported by, thepackage of iodine solution 32 such that it may easily be removed,leaving the iodine solution 32 supported by the bridge 44. One side ofthe iodine solution 32 may be pushed downward such that it pivots on thebridge 44, raising the opposite side of the package of iodine solutionso that it can easily be withdrawn from the tray 24. The side walls 43assist in this regard.

FIGS. 5 and 6 present a more detailed illustration of the main tray 26.Preferably, the remaining contents of the kit 10 (i.e., the items forproviding local anesthetic to the desired pierce site P and the primarynerve block items) are disposed within, or on, the main tray 26.

As mentioned previously, the sterile field tray 24 is desirably heldwithin the main tray 26. Advantageously, the main tray 26 includes asupport ledge 48 and a pair of stops 50 which are arranged to properlyposition the sterile field tray 24 and inhibit undesired movement. Asillustrated in FIG. 6, the support ledge 48 is spaced below the top ofthe main tray 26 such that, when supporting a corresponding lip of thesterile field tray 24, the top of the sterile field tray 24 is generallyflush with the top of the main tray 26.

Each of the pair of stops 50 protrudes from a wall of the main tray 26and have a top surface which is generally planar with the support ledge48. The stops 50 engage the sterile field tray 24 to hold it to one sideof the main tray 26 and, in addition, generally define a pair ofcompartments 52, 54 within the main tray 26. The compartment 52 isgenerally located on the side of the stops 50 where the sterile fieldtray 24 is held while the compartment 54 occupies the adjacent side ofthe main tray 26.

As illustrated in FIG. 6, each compartment 52, 54 includes a generallyplanar floor 56, 58, respectively. The floor 56 of compartment 52 is ata lower height than the floor 58 of compartment 54. That is, there is agreater height difference between the top of the main tray 26 and thefloor 56 than the height difference between the top of the main tray 26and the floor 58. Accordingly, a height H1 of a space S1 between thefloor 56 and the top of the main tray 26 is greater than the height H2of a space S2 between the floor 58 and the top of the main tray 26.Advantageously, the height H1 is sized such that the floor 56 will notinterfere with the bottom of the sterile field tray 24. Similarly, theheight H2 is sized such that certain other supplies may be held withinthe space S2, as will be described below.

With reference to FIG. 5, a plurality of recesses 60 are formed into themain tray 26. The recesses 60 are shaped such that a corresponding itemof the pain management kit 10 will fit within the recess 60 and,preferably, below the height of the floor 56, 58 that surrounds therecess 60. As illustrated, one or more of the recesses 60 may bedisposed partially in each of the compartments 52, 54 of the main tray26. Accordingly, such recesses 60 may be surrounded partially by each ofthe floors 56, 58, which are at different heights. In addition, ageneral recess 60 a is provided which is generally rectangular in shapeand may contain one or more items not necessarily of a correspondingshape.

Additionally, a plurality of access channels 62 and access depressions64 are formed into the main tray 26 proximate to one or more recesses60. Generally, the access channels 62 extend across, and connect, morethan one recess 60, while the access depressions 64 communicate with asingle recess 60. Both the access channels 62 and the access depressions64 provide a space for fingers of a user of the pain management kit 10when grasping a desired item and extract it from its recess 60.

Preferably, the items in the kit 10 that are relatively small and/orfragile (e.g., needles, syringes and vials) are held within a recess 60of a generally corresponding size and shape. Other larger and/or lessfragile items may be placed on top of the items contained in therecesses 60 in the spaces S1 or S2. As previously described, the sterilefield tray 24 is preferably disposed within the space S1, whileadditional items may be disposed in the space S2, as is described below.

The remaining items in the illustrated pain management kit 10 fall intogenerally two categories: (1) medical supplies necessary or desired toperform a local anesthetic procedure and (2) medical supplies necessaryor desired to perform the continuous nerve block procedure. Theseremaining items are generally contained in one of the recesses 60 or 60a and the space S2.

The local anesthetic supply contained in the kit 10 for performance of alocal anesthetic procedure preferably includes a variety of needles, oneor more vials of a local anesthetic, one or more vials of a sodiumchloride solution and one or more syringes. In the presently illustratedembodiment, two needles 68, 70 are contained within the kit 10,including a 22 gage×1.5″ needle 68 and a 25 gage×1.5″ needle 70. Ofcourse, needles of other sizes and diameters may be provided, as well asa greater or lesser quantity of needles, depending upon the desiredapplication of the pain management kit 10.

The illustrated embodiment of the pain management kit 10 also contains a3 cc plastic syringe 72 and a 5 cc plastic syringe 74. As will beappreciated by one of skill in the art, syringes of different sizes andmaterial types may be substituted for the previously described syringes72, 74, and a greater or lesser quantity of syringes may be includedwith the kit 10.

Additionally, the local anesthetic supply of the illustrated embodimentinclude a 5 ml vial of 1.0% Lidocaine solution 76 and a 5 ml vial of1.5% Lidocaine solution 78 for use as a local anesthetic and a 10 mlvial of 0.9% Sodium Chloride solution 80. The Sodium Chloride solution80 is useful to flush syringes and needles, as well as, a dilutant orsolvent for other drugs, such as the Lidocaine solutions 76 or 78. Ofcourse, other local anesthetic drugs and/or other dilutants or solventsmay be used, in different strengths and quantities.

The nerve block supply contained within the pain management kit 10preferably includes a Tuohy-type epidural needle 82, a needle extensionassembly 84, a glass syringe 86, a plastic syringe 88, a filter needle89, a catheter assembly 90 and an infusion system 92. Preferably, thesesupplies comprise the primary items necessary or desired to perform thecontinuous nerve block portion of the pain management procedure. A smallnumber of additional, non-disposable supplies may also be necessary ordesired, as will be described below.

The epidural needle 82 is preferably a 17 gage×3.5″ Tuohy-type needle,as is known in the art. The epidural needle 82 preferably includes anintegrated wire 83, or wires, constructed such that, when the wire 83 isconnected to a power source, an electrical current may flow through theneedle 82. Preferably, all but a distal tip portion of the needle 82 isinsulated, such that substantially no current will pass from the needleto another conductive object, except through the uninsulated tipportion. Needles of the type described immediately above arecommercially available.

The needle extension assembly 84 is a commercially available itemprimarily comprised of a tube with connectors at either end. A connectorat one end of the needle extension 84 is preferably configured such thatit will connect to the proximal end of the epidural needle 82. The otherconnector is preferably configured to connect to a variety of standardsyringes. Thus, the needle extension assembly 84 is primarily useful forconnecting a syringe to the epidural needle 82 and allowing fluidcommunication therebetween. In addition, a clamp may be provided on theneedle extension assembly 84 which is operable to selectively compressthe tube in order to occlude fluid flow.

The glass syringe 86 is preferably of a standard, 5 cc capacity variety.The glass syringe 86 is preferably capable of connection with theabove-described needle extension assembly 84, thereby being useful toinject a liquid contained in the syringe 86, through the needleextension assembly 84 and epidural needle 82, to a desired nerve blocksite B (FIG. 8). In addition, the glass syringe 86, preferably, is alsosuitable for connection to one of needles 68, 70 for the purpose ofloading the syringe 86 with a desired anesthetic from its vial.

The illustrated plastic syringe 88 is of a commercially availablevariety and preferably has a 10 cc capacity. The kit 10 additionallycontains a filter needle 89, which is preferably a 19 gage×1.5″commercially available filter needle. In combination, the plasticsyringe 88 and the filter needle 89 are useful to extract an anestheticdrug from a vial. The full syringe 88, with the needle 89 removed, maybe directly connected to a suitable fill hub on the infusion system 92.In this manner, the syringe 88 may be used to fill a reservoir of theinfusion system 92, as will be described in more detail below.

The illustrated catheter assembly 90 is a commercially availablecatheter suitable to transport a liquid drug from the infusion system 92to the desired block site. The catheter 90 is also preferably suitableto be threaded through the epidural needle 82, in a known manner, toreach the desired block site. A proximal end of the catheter includes aremovable connector 90 a suitable to connect to a connector of theinfusion system 92.

The infusion system 92 of the illustrated pain management kit 10 is alsocommercially available. With reference to FIG. 7, the infusion system 92generally comprises a reservoir 94 in fluid communication with a lengthof medical tubing 96. The tubing 96 connects the reservoir 94 with aconnector 97 suitable for connection to the connector 90 a of thecatheter 90, as described above. While stored within the kit 10, theinfusion system 92 is preferably disposed generally in the space S2.

The infusion system 92 preferably also includes a catheter holder 95,which is capable of securing both the connector 97 of the infusionsystem 92 and the exposed portion of the catheter 90. Preferably, thecatheter holder 95 has an adhesive backing suitable for use in a medicalenvironment. Thus, the catheter holder 95 is useful to inhibitunintentional removal of the catheter 90. A preferred catheter holder 95is commercially available under the brand name STATLOCK.

Preferably, a fill hub 98, a clamp 100 and a filter 102 are placed alongthe tubing 96, between the reservoir 94 and the connector 97. The fillhub 98 is capable of selectively permitting fluid communication betweena syringe, such as the above-described syringe 88, and the lumen of themedical tubing 96. The clamp 100 is a conventional clamp which issuitable to selectively permit, or occlude, fluid flow within the tubing96. The filter 102 is also commercially available and is suitable toseparate the drug from any contaminates found in the drug. The filter isalso suitable to eliminate air from the fluid path.

With reference to FIGS. 8 and 9, the items that are desirable forperforming the pain management procedure and are not included in thepain management kit 10 generally comprise a nerve stimulator 104 (i.e.,a current generating power source), an infusion pump 106, and theanesthetic 108. A desired nerve stimulator 104 is useful for generatinga current to be applied to the epidural needle 82, as described above. Adesired infusion pump 106 is useful for inducing a compressing force onthe reservoir 94 of the infusion system 92 to expel a drug containedtherein. The anesthetic drug 108 acts on the target nerve bundle toinhibit nerve signals from passing therethrough.

The nerve stimulator 104 is a non-sterile electronic device that isreusable. Therefore, it would be undesirable to include the nervestimulator 104 in the otherwise disposable pain management kit 10.Similarly, the infusion pump 106 is reusable and, therefore, would alsobe undesirable to include in the kit 10. The anesthetic drug 108 isdesirably not included with the pain management kit 10 because thechoice of drug 108 may vary widely among practitioners using the kit 10.

Method of Using the Pain Management Kit

The contents of the pain management kit 10, individually, and theirmethod of use, are generally known in the performance of continuousnerve blocks, and is understood by those of skill in the art. As such,the method of use of the kit 10 will be described only in general detailthat is helpful to exemplify certain features and advantages of the painmanagement kit 10. Specifically, the method of use of the painmanagement kit 10 will be described in relation to an interscalene blockprocedure (i.e., a nerve block of the brachial plexus at theinterscalene groove).

With primary reference to FIGS. 8 and 9, the continuous nerve blockprocedure is preferably performed in a prep room before the patiententers the OR. To begin the procedure, the protective cover 14 isremoved from the outer container 12, exposing the sterile wrap 23 (FIG.1). The tape is removed and the corners of the sterile wrap 23 arefolded back to expose the sterile medical supplies contained within thepain management kit 10. The absorbent towel 27 may be removed for lateruse.

To create a sterile field, the drape 28 is removed from its place on thesterile field tray 24, and is unfolded and placed over the patient. Thedrape 28 is positioned such that the pierce site P is exposed within thecutout. For the purpose of clarity, the drape 28 has been omitted fromFIGS. 8 and 9. The skin prep pad 30 is used to clean the patient's skinin the area surrounding the pierce site P. The iodine solution 32 isthen applied to the skin surrounding the pierce site P with one or moreof the prep sticks 34, in order to sterilize the pierce site P.Advantageously, the sterile field tray 24 may then be removed to exposethe contents of the main tray 26.

To perform the local anesthetic procedure, one of the needles 68, 70 andone of the syringes 72, 74 are removed from their respective recesses 60and assembled. One of the vials of Lidocaine 76, 78 are selected,removed from its recess 60 and opened. The syringe and needle assembly(not shown) is loaded with Lidocaine with the Sodium Chloride solution80 being optionally used as a dilutant. An injection is then madeproximate to the desired pierce site P to anesthetize the area forinsertion of the epidural needle 82. The gauze pads 36 may be removedfrom the sterile field tray 24, which has been set aside, and used tocontrol any bleeding that may occur due to the injection of localanesthetic.

To perform the actual nerve block portion of the procedure, first, theinfusion system 92 is removed from the pain management kit 10, therebyexposing the other contents of the kit 10 disposed in the recesses 60,60 a disposed in compartment 54. The reservoir 94 of the infusion system92 is filled with the anesthetic drug 108 by selecting the plasticsyringe 88 and assembling the filter needle 89 thereto. Thesyringe/needle assembly 88/89 is then loaded with drug 108. The needle88 is removed and the syringe 88 is connected to the fill hub 98 of theinfusion system 92. The drug is then transferred from the syringe 88 tothe reservoir 94. This procedure is repeated until the reservoir 94 issufficiently full. Optionally, this step may be performed before thelocal anesthetic procedure, and the filled infusion system 92 may be setaside for later use.

With reference to FIG. 8, the epidural needle is removed from its recess60 and the wire 83 of the epidural needle 82 is connected to the nervestimulator 104. Next, the glass syringe 86 is removed from itscorresponding recess 60 and is loaded with the anesthetic drug 108. Theloaded glass syringe 86 is connected to the epidural needle 82 using theneedle extension assembly 84 located in the pain management kit 10. Theepidural needle 82 is inserted into the patient at the pierce site P andis advanced toward the block site B. The nerve stimulator 104 isactivated such that current is pulsed through the epidural needle 82,preferably at about 0.2–0.5 milli-Amps (mA). The current through theneedle 82 induces a motor response and when such a response is presentat low current, proper placement of the epidural needle 82 is achieved.An injection of drug 108 from the glass syringe 86 is made and properneedle 82 placement is verified by a subsequent lack of motor response.Thereafter, the nerve stimulator 104 is shut down and the syringe 86 andneedle extension assembly 84 are removed from the epidural needle 82.

The catheter 90 is inserted through the needle 82 until it reaches thedesired block site B. The epidural needle 82 is withdrawn, leaving thecatheter 90 in place. Next, the removable connector is assembled to thecatheter 90. The filled infusion system 92 is connected to the catheter90 and the reservoir 94 is placed in an infusion pump 106. The pump 106is activated such that the drug 108 is expelled from the reservoir 94and infusion system 92 through the catheter 90 and is delivered to theblock site at a controlled rate. The drug 108 is administered in thismanner over a period of time (e.g., 2–3 days). The portions of the painmanagement kit 10 remaining, including the outer container 12,protective cover 14, sterile field tray 24 and main tray 26, may then bedisposed of in an appropriate manner, including recycling, ifappropriate. Advantageously, the nerve stimulator 104 and the infusionpump 106 may be stored, or prepared, for use in a subsequent procedure.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above, but should be determined only by a fairreading of the claims that follow.

1. A pain management kit for performing a nerve block procedure,comprising: a first tray having a bottom wall, a side wall extendingfrom an entire periphery of said bottom wall, and an upper rim extendingoutwardly from an entire periphery of an upper end of said side wall,said first tray defining an interior space; a sterile wrap; a secondtray positioned within said first trays; a third fray positioned withinsaid second trays; a planar, protective cover releaseably attached to anentire periphery of said upper rim of said first tray to cover an openupper end of said first tray; wherein said sterile wrap includes acentral portion positioned within said interior space of said first trayand a peripheral portion surrounding said central portion, said secondtray positioned on top of said central portion of said sterile wrap,said second tray being sized and shaped to occupy a substantial entiretyof said bottom wall of said first tray, a bottom wall of said secondtray defining a plurality of recesses and being divided into a firstportion and a second portion, wherein a first distance is definedbetween said upper rim and said first portion and a second distance isdefined between said upper rim and said second portion, said firstdistance being greater than said second distance, said third traypositioned within said first portion of said second tray, a bottom wallof said third tray being sized and shaped to occupy a substantialentirety of said bottom wall of said first portion of said second trayand not extend into said second portion of said second tray; whereinsaid recesses of said second tray hold a collection of local anestheticand continuous nerve block supplies and wherein said third tray holds acollection of sterile field supplies; wherein said peripheral portion ofsaid sterile wrap is folded to cover said second tray and said thirdtray before said cover is attached to said first tray.
 2. The kit ofclaim 1, wherein second tray includes a pair of stops between said firstportion and said second portion, said stops configured to contact saidthird tray and prevent said third tray from moving into said secondportion of said second tray.
 3. The kit of claim 2, wherein said pair ofstops are integrally formed with a side wall of said second tray.
 4. Thekit of claim 1, wherein said bottom wall of said third tray defines anarea greater than one-half of an area defined by said bottom wall ofsaid second tray.
 5. The kit of claim 1, wherein said third trayincludes an interior wall dividing an interior space of said third trayinto a first section and a second section, wherein said first section issized and shaped to accommodate a plurality of prep sticks.
 6. The kitof claim 1, additionally comprising an adhesive-backed catheter holder,said catheter holder configured to secure an external section of saidcatheter to a patient.
 7. The kit of claim 1, wherein both of said firsttray and said second tray are rectangular in shape.
 8. The kit of claim7, wherein said third tray is rectangular in shape.